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Active, Not Recruiting

NCT Number: NCT00594789

Closing The Post Fracture Care Gap In Manitoba

The objective of this study is to evaluate a post-fracture intervention for improving osteoporosis care in older men and women who have suffered a fracture that may indicate the presence of osteoporosis. Although osteoporosis can be identified with a bone mineral density (BMD) test, most individuals with osteoporosis are not diagnosed until they fracture. Post-fracture care often "falls between the cracks" when there is a breakdown in communication between hospital and community, or between specialists and primary care physicians. Often physicians and patients fail to make the connection between an acute fracture and osteoporosis, or the value of secondary prevention strategies. If untreated, there is an extremely high rate of additional fractures after a first osteoporotic fracture. It follows that improving BMD testing and/or treatment in appropriately identified individuals is a necessary step in optimizing post-fracture patient care. Over the next three years we will be testing and optimizing a notification procedure to physicians and/or patients relying upon fracture events reported to the provincial health service (Manitoba Health).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Fractures, Bone Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Wounds and Injuries

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

About this study

A major 'care gap' exists in the management of patients with fractures suggestive of osteoporosis. Currently, only a small minority of these individuals who are at high risk for recurrent fractures undergo evaluation for possible treatment. We propose to test and optimize a novel approach to address this question, relying upon fracture events reported to provincial health service (Manitoba Health) as a mechanism for osteoporosis case identification and enhancing post fracture care.

Phase 1 (one year duration): individuals meeting the fracture case definition will be randomized to usual care (no intervention), physician notification and physician/patient notification. The notification will provide a general recommendation for osteoporosis assessment. The use of appropriate post-fracture investigations and treatment will be prospectively evaluated.

Phase 2 (up to two years duration): the intervention will be refined and iteratively trialed for all individuals meeting the fracture case definition.

Phase 3: a recommendation for long term maintenance of the post-fracture intervention will be developed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women and men age 50 and older with one of the following fracture definitions:
  • Hip fracture (physician ICD-9-CM 820-821 plus a procedure code for site-specific fracture reduction or fixation, open or closed)
  • Spine fracture (physician ICD-9-CM code 805), or
  • Humerus fracture (physician ICD-9-CM code 812), or
  • Colles' fracture (physician ICD-9-CM code 813 plus a physician claim for site-specific fracture reduction or fixation, open or closed, or cast application).

Exclusion criteria

  • Age less than 50.
  • Non-Manitoba residents, cancelled Manitoba Health coverage, death or discharge to a personal care home.
  • A fracture event in the previous 12 months meeting the study case definition (i.e., only a single notification per year is planned).
  • Hip or wrist fractures without a procedure tariff.
  • Current treatment with an osteoporosis medication.
  • BMD testing within the preceding 3 years.

Treatment and study plan

Information letters

Other

Information letters under Manitoba Health letterhead will be sent out to physician(s) and/or patient connected with a fracture that meets specific criteria. To address concerns over discontinuous care of patient seen at the time of fracture and for subsequent follow-up, the physician notification will specifically target the individual involved in the initial report to Manitoba Health as well as the primary care physician (using an algorithm developed by the Manitoba Centre for Health Policy). The notification will provide a general recommendation for osteoporosis assessment in addition to a copy of the BMD testing requisition since BMD testing is usually justified in this setting. The notification will not dictate what testing or treatment needs to be performed.

Primary outcomes

  1. Rates of BMD testing and/or osteoporosis pharmacotherapy in the year post-fracture using the population-based provincial administrative health data repository.

    Time frame: 3 years (Phase 1 analysis at 1 year)

Secondary outcomes

  1. For individuals referred for BMD testing, an evaluation of treatment appropriateness will be performed based upon BMD results and 10-year fracture risk methods.

    Time frame: 3 years (Phase 1 analysis at 1 year)

  2. Repeat fracture rates will be also studied as a secondary endpoint.

    Time frame: 3 years (Phase 1 analysis at 1 year)

  3. An evaluation of post-fracture BMD testing and treatment rates in the years prior to the Phase 1 will also be performed to document practice patterns before the intervention.

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • The Manitoba Bone Density Program Committee
  • The Manitoba Patient Access Network Steering Committee

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2028
First posted
Jan 16, 2008
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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